ChiCTR2500102203 版本V1.2 版本创建时间2026/02/14 09:39:34 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

ChiCTR2500102203 

最近更新日期：

Date of Last Refreshed on：

2025-05-15 17:09:11 

注册时间：

Date of Registration：

2025-05-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评价 BW-201(Adi1)在18岁及以上健康成人中安全性、耐受性和免疫原性的随机、盲法、安慰剂对照的I期临床试验方案

Public title：

A Randomized, Blinded, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of BW-201 (Adi1) in Healthy Adults Aged 18 Years and Older

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项评价 BW-201(Adi1)在18岁及以上健康成人中安全性、耐受性和免疫原性的随机、盲法、安慰剂对照的I期临床试验方案

Scientific title：

A Randomized, Blinded, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of BW-201 (Adi1) in Healthy Adults Aged 18 Years and Older

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

蒋林芮 

研究负责人：

靳飞 

Applicant：

Linrui Jiang 

Study leader：

Fei Jin 

申请注册联系人电话：

Applicant telephone：

+86 181 0217 2753

研究负责人电话：

Study leader's telephone：

+86 137 2279 5742

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

jianglinrui@benewill.com

研究负责人电子邮件：

Study leader's E-mail：

ycjf3000@126.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

北京市北京经济技术开发区瑞合西二路8号院 2号楼 101室

研究负责人通讯地址：

河北省石家庄市槐安东路97号

Applicant address：

Room 101, Building 2, Yard 8, Ruihe West 2nd Road, Beijing Economic-Technological Development Area, Beijing, China

Study leader's address：

No. 97, Huai’an East Road, Shijiazhuang, Hebei Province, China

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

北京百邑无忧科技发展有限公司

Applicant's institution：

Beijing BeneWill Technology Development Co., Ltd

研究负责人所在单位：

河北省疾病预防控制中心

Affiliation of the Leader：

Hebei Provincial Center for Disease Control and Prevention

是否获伦理委员会批准：

是/Yes

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

HeBIRB2025-002

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

河北省疾病预防控制中心伦理委员会

Name of the ethic committee：

Ethics Committee of Hebei Provincial Center for Disease Control and Prevention

伦理委员会批准日期：

Date of approved by ethic committee：

2025-03-26 00:00:00

伦理委员会联系人：

靳飞

Contact Name of the ethic committee：

Fei Jin

伦理委员会联系地址：

河北省石家庄市槐安东路97号

Contact Address of the ethic committee：

No. 97, Huai’an East Road, Shijiazhuang, Hebei Province, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

+86 311 8657 3167

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

河北省疾病预防控制中心

Primary sponsor：

Hebei Provincial Center for Disease Control and Prevention

研究实施负责（组长）单位地址：

河北省石家庄市槐安东路97号

Primary sponsor's address：

No. 97, Huai’an East Road, Shijiazhuang, Hebei Province, China

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

北京市

市(区县)：

北京市

Country：

China

Province：

Beijing

City：

Beijing

单位(医院)：

北京百邑无忧科技发展有限公司

具体地址：

北京市北京经济技术开发区瑞合西二路8号院 2号楼 101室

Institution
hospital：

Beijing BeneWill Technology Development Co., Ltd

Address：

Room 101, Building 2, Yard 8, Ruihe West 2nd Road, Beijing Economic-Technological Development Area, Beijing, China

经费或物资来源：

自筹

Source(s) of funding：

Self-funded

Target disease：

Lower Respiratory Tract Disease (LRTD) caused by Respiratory Syncytial Virus (RSV)

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的：评价接种1剂RSV疫苗(BW-201(Adi1))后一个月(至D30)内的安全性和耐受性。 次要目的: 评价接种1剂RSV疫苗(BW-201(Adj1))的体液免疫反应。 评价接种1剂RSV疫苗(BW-201(Adi1))的细胞免疫反应。 评价接种1剂RSV疫苗(BW-201(Adi1))在试验随访期间(至M12)的安全性。  

Objectives of Study：

Primary Objective: To evaluate the safety and tolerability of a single dose of RSV vaccine (BW-201 (Adi1)) within one month (up to Day 30) after vaccination. Secondary Objectives: To evaluate the humoral immune response to a single dose of RSV vaccine (BW-201(Adi1)). To evaluate the cellular immune response to a single dose of RSV vaccine (BW-201 (Adi1)). To evaluate the safety of a single dose of RSV vaccine (BW-201 (Adi1)) during the study follow-up period (up to Month 12).

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1. 自愿参加本临床试验，能够正确理解并自愿签署ICF，能够遵守ICF中所列出的要求和限制； 2. 入组时年龄为18~59岁或≥60岁的成年男性或女性； 3. 根据病史、生命体征、体格检查、实验室检查（*）、心电图检查（*）等结果，经研究者临床判断结果正常或异常无临床意义，可以纳入本试验的健康成人；（注：伴有既往存在的稳定疾病的健康受试者允许纳入本试验，既往存在的稳定疾病定义为入组前6周内的疾病未加重，不需要显著改变治疗方法或不需要住院治疗）； 4. 愿意并能够配合研究人员，遵守并按照试验方案要求完成计划访视、免疫接种、实验室检查及其他试验程序； 5. 育龄期女性（WOCBP，定义见附录1）受试者在入组时尿妊娠试验须为阴性，自从签署ICF开始至接种试验用疫苗后3个月内，需采用有效避孕措施（见附录1）。

Inclusion criteria

1. Willingness to participate in this clinical trial, the ability to fully understand and voluntarily sign the informed consent form (ICF), and the ability to comply with the requirements and restrictions outlined in the ICF. 2. Adult male or female participants aged 18 to 59 years, or >= 60 years, at the time of enrollment. 3. Healthy adults who, based on medical history, vital signs, physical examination, laboratory tests (*), and electrocardiogram (*), are determined by the investigator to be normal or have abnormalities of no clinical significance, and are eligible for inclusion in the study. (Note: Healthy participants with stable pre-existing conditions are allowed to be enrolled in the study. Stable pre-existing conditions are defined as conditions that have not worsened in the 6 weeks prior to enrollment and do not require significant changes in treatment or hospitalization.) 4. Willing and able to cooperate with the investigators, and to comply with and complete the scheduled visits, immunization, laboratory tests, and other study procedures as required by the protocol. 5. Female participants of childbearing potential (WOCBP, as defined in Appendix 1) must have a negative urine pregnancy test at the time of enrollment and must use effective contraception (as defined in Appendix 1) from the time of signing the ICF until 3 months after receiving the study vaccine.

排除标准：

1. *接种试验用疫苗当天或接种试验用疫苗前72小时内发热（腋温≥37.3℃）； 2. *接种试验用疫苗前72小时内，患急性疾病或处于慢性病的急性发作期或使用退热镇痛或抗过敏药物； 3. 既往接种过任何RSV疫苗或计划接种除本品外的RSV疫苗； 4. 接种试验用疫苗前6个月内，经问诊有RSV感染史； 5. 体重指数（BMI）<18.5 kg/m^2或>32.5 kg/m^2； 6. *经体检测量的血压升高（18~59岁人群：收缩压≥140mmHg或者舒张压≥90mmHg；60岁及以上人群：收缩压≥160mmHg或者舒张压≥100mmHg）； 7. 既往对试验用疫苗任何成分过敏或既往接种疫苗有严重过敏反应史，例如：过敏性休克、严重荨麻疹、呼吸困难、过敏性喉头水肿、血管神经性水肿、过敏性紫癜、血小板减少性紫癜、局部过敏坏死反应（Arthus反应）等；既往接种疫苗后出现格林-巴利综合征者； 8. *接种试验用疫苗前6个月内长期使用（连续使用≥14天）免疫抑制剂或其他免疫调节类药物（例如糖皮质类激素：强的松或同类药物，剂量≥2mg/kg/天或≥20mg/天泼尼松或相当于泼尼松剂量），但允许局部用药（如软膏、滴眼液、吸入剂或鼻喷剂），局部用药不得超过说明书中推荐的剂量或有任何全身性暴露体征者； 9. 根据已知病史或诊断确认患有影响免疫系统功能的疾病，包括但不限于：癌症（皮肤基底细胞癌除外），先天性或获得性的免疫缺陷（例如：人类免疫缺陷病毒[HIV]感染），自身免疫性疾病（例如：系统性红斑狼疮、类风湿关节炎），无脾或功能性无脾； 10. 存在经研究者判断的影响本试验计划程序或结果评价的严重或不可控制的呼吸系统疾病、甲状腺疾病、心血管疾病、神经系统疾病、精神疾病、血液和淋巴系统疾病、肝肾疾病、代谢及骨骼等系统疾病； 11. 有出血倾向或凝血功能异常（例如细胞因子缺陷、凝血障碍或血小板失调），或有严重出血史，或有肌内注射或静脉穿刺后大量出血史； 12. 既往或现患乙肝、丙肝和梅毒者； 13. *接种试验用疫苗前30天内接种过或接种后30天内计划接种减毒活疫苗，或接种前14天内接种过或接种后14天内计划接种其他除试验用疫苗以外的任何疫苗； 14. *接种试验用疫苗前30天内（或试验药物5个半衰期内）或计划在本试验期间使用任何试验性或未注册的药物或疫苗； 15. *接种试验用疫苗前3个月内及试验期间计划使用免疫球蛋白和/或血液制品； 16. 存在酗酒或酒精依赖（如无法控制饮酒行为，有对酒精的依赖性）或药物滥用的情况； 17. 处于妊娠期或哺乳期的女性，或计划自从签署ICF开始至接种试验用疫苗后3个月内进行捐卵者； 18. 计划试验结束前从本地区永久搬迁或在试验访视期间长期离开本地者； 19. 参与本试验执行的研究中心、申办者、合同研究组织（CRO）的工作人员； 20. 研究者认为不适宜参加本试验的其他情况。

Exclusion criteria：

1. *Fever (axillary temperature >= 37.3°C) on the day of vaccination or within 72 hours prior to vaccination with the investigational vaccine. 2. *Acute illness or acute exacerbation of a chronic illness, or the use of antipyretic, analgesic, or anti-allergic medications within 72 hours prior to vaccination with the investigational vaccine. 3. Previous vaccination with any RSV vaccine or planned vaccination with any RSV vaccine other than the investigational product. 4. History of RSV infection within the past 6 months prior to vaccination, based on medical history. 5. Body mass index (BMI) < 18.5 kg/m2 or > 32.5 kg/m2. 6. Hypertension measured by physical examination (18-59 years: systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg; >= 60 years: systolic blood pressure >= 160 mmHg or diastolic blood pressure >= 100 mmHg). 7. History of severe allergic reactions to any component of the investigational vaccine, or a history of severe allergic reactions to previous vaccines, such as anaphylactic shock, severe urticaria, dyspnea, allergic laryngeal edema, angioedema, allergic purpura, thrombocytopenic purpura, or local allergic necrotic reactions (Arthus reactions); history of Guillain-Barré syndrome following previous vaccination. 8. *Use of immunosuppressive or other immune-modulating drugs (e.g., corticosteroids: prednisone or equivalent at >= 2 mg/kg/day or >= 20 mg/day) for >= 14 consecutive days within the past 6 months prior to vaccination, except for localized treatments (e.g., ointments, eye drops, inhalers, or nasal sprays), which must not exceed the recommended dose or show signs of systemic exposure. 9. Known medical history or diagnosed conditions that affect immune system function, including but not limited to: cancer (except for basal cell carcinoma of the skin), congenital or acquired immunodeficiency (e.g., HIV infection), autoimmune diseases (e.g., systemic lupus erythematosus, rheumatoid arthritis), asplenia or functional asplenia. 10. Severe or uncontrolled respiratory diseases, thyroid disease, cardiovascular diseases, neurological disorders, psychiatric disorders, hematologic and lymphatic diseases, liver and kidney diseases, metabolic or skeletal disorders, or any other condition that, in the investigator's judgment, may affect the study protocol or outcomes. 11. History of bleeding disorders or coagulopathy (e.g., cytokine deficiencies, coagulation disorders, or platelet dysfunction), or history of severe bleeding, or significant bleeding after intramuscular injection or venipuncture. 12. History of or current infection with hepatitis B, hepatitis C, or syphilis. 13. *Receipt of or planned receipt of live attenuated vaccines within 30 days prior to vaccination or within 30 days after vaccination with the investigational vaccine, or receipt of or planned receipt of any vaccine (other than the investigational vaccine) within 14 days prior to vaccination or within 14 days after vaccination. 14. *Use or planned use of any investigational or unapproved drugs or vaccines within 30 days prior to vaccination (or within 5 half-lives of the investigational drug), or during the study. 15. *Planned use of immunoglobulins and/or blood products within 3 months prior to vaccination or during the study period. 16. History of alcohol abuse or alcohol dependence (e.g., inability to control drinking behavior, dependence on alcohol) or drug abuse. 17. Pregnant or breastfeeding women, or women planning to donate eggs within 3 months after signing the ICF and prior to vaccination with the investigational vaccine. 18. Participants planning to permanently relocate from the area or leave the area for an extended period during the study. 19. Staff members of the study center, sponsor, or contract research organization (CRO) conducting the study. 20. Any other conditions that the investigator deems unsuitable for participation in the study.

研究实施时间：

Study execute time：

从 From 2025-05-12 00:00:00至 To 2026-05-11 00:00:00  

征募观察对象时间：

Recruiting time：

从From 2025-05-12 00:00:00 至 To 2026-05-11 00:00:00  

干预措施：

Interventions：

组别：

BW-201 (Adj 1)低剂量组

样本量：

32

Group：

BW-201 (Adj 1) low dose group

Sample size：

干预措施：

本品接种1次，60ug，给药前抗原和佐剂必需混合使用。将佐剂瓶上下颠倒5~10次混匀， 吸取全部佐剂溶液加入到抗原中进行复溶，等待2~5分钟后，缓慢旋转瓶身至完全溶解。每人每次取0.5mL于上臂外侧三角肌肌肉注射，严禁静脉注射。

干预措施代码：

Intervention：

This product is administered once, 60ug. The antigen and adjuvant must be mixed prior to administration. The adjuvant vial should be inverted 5 to 10 times to mix thoroughly. The entire volume of the adjuvant should then be added to the antigen for reconstitution. After waiting for 2 to 5 minutes, gently swirl the vial until the solution is fully dissolved. Each subject will receive 0.5 mL via intramuscular injection into the deltoid muscle of the upper arm. Intravenous injection is strictly prohibited

Intervention code：

组别：

BW-201 (Adj 1) 高剂量组

样本量：

32

Group：

BW-201 (Adj 1) high dose group

Sample size：

干预措施：

本品接种1次，120ug，给药前抗原和佐剂必需混合使用。将佐剂瓶上下颠倒5~10次混匀， 吸取全部佐剂溶液加入到抗原中进行复溶，等待2~5分钟后，缓慢旋转瓶身至完全溶解。每人每次取0.5mL于上臂外侧三角肌肌肉注射，严禁静脉注射。

干预措施代码：

Intervention：

This product is administered once, 120ug. The antigen and adjuvant must be mixed prior to administration. The adjuvant vial should be inverted 5 to 10 times to mix thoroughly. The entire volume of the adjuvant should then be added to the antigen for reconstitution. After waiting for 2 to 5 minutes, gently swirl the vial until the solution is fully dissolved. Each subject will receive 0.5 mL via intramuscular injection into the deltoid muscle of the upper arm. Intravenous injection is strictly prohibited

Intervention code：

组别：

氯化钠注射液组

样本量：

32

Group：

Sodium Chloride Injection group

Sample size：

干预措施：

每人每次取0.5mL 于上臂外侧三角肌肌肉注射，严禁静脉注射。

干预措施代码：

Intervention：

Each subject will receive 0.5 mL via intramuscular injection into the deltoid muscle of the upper arm; intravenous injection is strictly prohibited.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

 定兴县 

Country：

China 

Province：

Heibei 

City：

Dingxing 

单位(医院)：

河北省定兴县疾病预防控制中心 

单位级别：

N/A 

Institution
hospital：

Dingxing County Center for Disease Control and Prevention, Hebei Province

Level of the institution：

N/A

测量指标：

Outcomes：

指标中文名：

接种后14天内征集性AE发生率、发生类型和严重程度

指标类型：

主要指标

Outcome：

Incidence, type, and severity of solicited adverse events (AEs) within 14 days after vaccination.

Type：

Primary indicator

测量时间点：

接种后14天内

测量方法：

Measure time point of outcome：

Within 14 days after vaccination

Measure method：

指标中文名：

接种后30天内非征集性AE发生率、发生类型和严重程度

指标类型：

主要指标

Outcome：

Incidence, type, and severity of unsolicited AEs within 30 days after vaccination.

Type：

Primary indicator

测量时间点：

接种后30天内

测量方法：

Measure time point of outcome：

Within 30 days after vaccination

Measure method：

指标中文名：

接种后30天内AESI发生率、发生类型和严重程度

指标类型：

主要指标

Outcome：

Incidence, type, and severity of Adverse Events of Special Interest (AESIs) within 30 days after vaccination.

Type：

Primary indicator

测量时间点：

接种后30天内

测量方法：

Measure time point of outcome：

Within 30 days after vaccination

Measure method：

指标中文名：

接种后30天内SAE发生率、发生类型

指标类型：

主要指标

Outcome：

Incidence, type, and severity of Serious Adverse Events (SAEs) within 30 days after vaccination.

Type：

Primary indicator

测量时间点：

接种后30天内

测量方法：

Measure time point of outcome：

Within 30 days after vaccination

Measure method：

指标中文名：

接种前及接种后14天、30天抗RSV A和抗RSV B中和抗体滴度。

指标类型：

次要指标

Outcome：

Titers of neutralizing antibodies against RSV A and RSV B before vaccination and 14 and 30 days after vaccination.

Type：

Secondary indicator

测量时间点：

接种前及接种后14天、30天

测量方法：

Measure time point of outcome：

Pre-vaccination and at 14 and 30 days post-vaccination

Measure method：

指标中文名：

接种前及接种后14天、30天BW-201抗原（preF）RSV A和B两种型的特异性IgG抗体浓度。

指标类型：

次要指标

Outcome：

Concentrations of RSV A and B subtype-specific IgG antibodies against the BW-201 antigen (RSV pre-fusion F protein, preF) before vaccination and 14 and 30 days after vaccination.

Type：

Secondary indicator

测量时间点：

接种前及接种后14天、30天

测量方法：

Measure time point of outcome：

Pre-vaccination and at 14 and 30 days post-vaccination

Measure method：

指标中文名：

接种前及接种后14天的BW-201（preF）特异性T细胞分泌IFN-γ水平（Elispot法）。

指标类型：

次要指标

Outcome：

Levels of BW-201 antigen (preF)-specific T cells secreting IFN-γ (Elispot method) before vaccination and 14 days after vaccination.

Type：

Secondary indicator

测量时间点：

接种前及接种后14天

测量方法：

Measure time point of outcome：

Pre-vaccination and at 14 days post-vaccination

Measure method：

指标中文名：

接种前及接种后14天的BW-201（preF）特异性IFN-γ阳性、IL-2阳性、IFN-γ和IL-2双阳性CD8+ T细胞频率（胞内细胞因子染色/ICS法）。

指标类型：

次要指标

Outcome：

Frequency of IFN-γ-positive, IL-2-positive, and dual-positive (IFN-γ and IL-2) CD4+ T cells in response to BW-201 antigen (preF) by intracellular cytokine staining (ICS method) before vaccination and 14 days after vaccination.

Type：

Secondary indicator

测量时间点：

接种前及接种后14天

测量方法：

Measure time point of outcome：

Pre-vaccination and at 14 days post-vaccination

Measure method：

指标中文名：

接种后第3天实验室检查指标的变化。

指标类型：

次要指标

Outcome：

Changes in laboratory test results on Day 3 after vaccination.

Type：

Secondary indicator

测量时间点：

接种后第3天

测量方法：

Measure time point of outcome：

On Day 3 post-vaccination

Measure method：

指标中文名：

接种后12个月内SAE/AESI发生情况。

指标类型：

次要指标

Outcome：

Incidence of SAEs/AESIs within 12 months after vaccination.

Type：

Secondary indicator

测量时间点：

接种后12个月内

测量方法：

Measure time point of outcome：

Within 12 months post-vaccination

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血液

组织：

Sample Name：

Blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age N/A 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

由随机化统计师使用SAS9.4或以上版本的软件生成受试者随机表。受试者随机设计：各年龄、剂量队列采用区组随机化方法，按照方案规定的比例（2:1）将受试者随机分配至试验组（BW-201（Adj 1））和安慰剂组，各年龄、剂量队列设置3名哨兵，按照试验组（BW-201（Adj 1））：安慰剂组=2:1，在最后1例哨兵受试者完成接种至少7天后，由SRC评估受试者安全性，如经评估未达试验暂停/终止标准，再入组该队列剩余受试者。研究者严格按照筛选合格的受试者的入选顺序依次分配相应现场的研究编号，根据编号获取和接种试验用疫苗。 本试验准备备用疫苗18支（备001-备018），60μg试验组、120μg试验组、安慰剂组比例为1:1:1。由随机化统计师采用SAS统计软件产生备用疫苗随机分配表。当研究需要使用备用疫苗时，由研究者登陆中央随机化系统的备用疫苗模块获取相应编号的备用疫苗。

Randomization Procedure (please state who generates the random number sequence and by what method)：

The randomization list will be generated by the study statistician using SAS version 9.4 or higher. Randomization Design: For each age and dose cohort, a block randomization method will be used to allocate subjects to the investigational group (BW-201 (Adj 1)) or the placebo group in a 2:1 ratio, as specified in the protocol. In each age and dose cohort, three sentinel subjects will be enrolled and randomized in a 2:1 ratio (BW-201 (Adj 1): Placebo). Safety data of sentinel subjects will be reviewed by the Safety Review Committee (SRC) at least 7 days after the last sentinel subject receives the vaccination. If no study-halting or termination criteria are met, the remaining subjects in the cohort may then be enrolled. Investigators will strictly follow the order of subject eligibility for assignment and allocate investigational product according to the site-specific randomization number. A total of 18 backup vaccine doses (labeled Backup 001–Backup 018) will be prepared for this study, with an equal allocation ratio of 1:1:1 among the 60 μg dose group, the 120 μg dose group, and the placebo group. A backup vaccine randomization list will be generated by the study statistician using SAS. When a backup dose is needed, the investigator will access the backup vaccine module in the central randomization system to obtain the corresponding backup vaccine number

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

本试验由随机化统计师与不参与临床试验的编盲人员进行疫苗编盲，即按照盲底将打印好的疫苗标签粘贴于每份疫苗指定位置。由随机化统计师督导疫苗编盲，指导编盲操作人员按照盲底进行贴签，完成编盲后，由随机化统计师封存、保管盲底。整个编盲过程须有文字记录。编盲人员不得参加本临床试验的其他相关工作，同时也不得向参加本临床试验工作的任何人员泄露盲底。 由于本试验中试验疫苗及安慰剂外观上存在差异，将设置专门的非盲研究人员进行试验疫苗接收、保管、配制、接种、回收、退还工作，非盲研究人员不得参与盲态研究工作并签署保密协议保证不会将相关信息透露给盲态工作人员，以保持受试者、研究者、申办者及其他研究相关工作人员的盲态，即“观察者盲”。 在整个试验过程中，进行免疫原性分析的实验室人员将对受试者的分配治疗全程保持盲态。

Blinding：

Blinding of the investigational vaccine will be performed by the study statistician and designated unblinded personnel who are not involved in the conduct of the clinical trial. Vaccine labels will be printed and affixed to the designated location on each vaccine unit according to the randomization code (blinding list). The study statistician will supervise and guide the unblinded personnel during the labeling process to ensure it is performed in accordance with the blinding list. Upon completion, the blinding list will be sealed and securely stored by the statistician. The entire blinding process must be documented in writing. Unblinded personnel must not participate in any other aspect of the clinical trial and are strictly prohibited from disclosing any information from the blinding list to blinded study personnel. Due to visual differences between the investigational vaccine and placebo in this trial, specific unblinded staff will be assigned to handle vaccine receipt, storage, preparation, administration, return, and disposal. These unblinded staff must not engage in any blinded study activities and must sign a confidentiality agreement to ensure that no information is disclosed to blinded personnel. This is to maintain the blind for subjects, investigators, the sponsor, and all other study-related personnel (i.e., an "observer-blind" design). Throughout the trial, laboratory personnel performing immunogenicity analyses will remain blinded to the treatment allocation of all subjects.

是否共享原始数据：

IPD sharing

No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

N/A

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

N/A

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

1.研究人员需按照试验方案要求来收集受试者数据，并根据原始资料参照填写指南把信息准确、及时、完整、规范地填写到eCRF中。eCRF数据的修改必须遵照标准操作程序，保留修改痕迹。 2. 数据管理部门DM撰写详细的数据核查计划，数据录入到EDC后，系统按照数据核查计划书中所建编辑核查（Edit Check）将对数据进行核查，有疑问的数据会自动发出系统质疑；无法设置为系统发出疑问的数据会通过EDC发送人工疑问，研究者或其授权的人员对人工质疑和系统质疑进行确认和回答，必要时修改错误数据，直至质疑解决。回答未能解决质疑时，数据管理员和临床监查员可以对该数据点进行一次再质疑，所有的留痕均保存在EDC数据库中。研究人员需按照试验方案要求来收集受试者数据，并根据原始资料参照填写指南把信息准确、及时、完整、规范地填写到eCRF中。eCRF数据的修改必须遵照标准操作程序，保留修改痕迹

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

1. Investigators are required to collect subject data in accordance with the clinical trial protocol and accurately, promptly, completely, and properly enter the data into the electronic Case Report Form (eCRF) based on the source documents and following the eCRF completion guidelines. Any changes to eCRF data must comply with the standard operating procedures (SOPs), with audit trails maintained for all modifications. 2. The Data Management (DM) department will develop a detailed Data Validation Plan (DVP). Once data are entered into the Electronic Data Capture (EDC) system, programmed edit checks will be applied as specified in the DVP to verify data quality. Queries will be automatically generated by the system for discrepant or suspicious data. For issues that cannot be captured by system-generated queries, manual queries will be raised through the EDC system.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2025-05-12 08:58:12